Third Cohort of Patients Continues to Show Clinically Meaningful Responses in the Evaluation of GEN-1, A Novel IL-12 DNA-based Immunotherapy, in Combination with the Standard of Care

Top Line Translational Data from First Two Cohorts Demonstrates Potential Immune Activation

LAWRENCEVILLE, N.J., Nov. 10, 2016 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ:CLSN) today announced data from the third cohort of patients in its Phase Ib dose escalating clinical trial (the OVATION Study) combining GEN-1, the Company's DNA-based immunotherapy, with the standard of care for the treatment of newly-diagnosed patients with advanced ovarian cancer who will undergo neoadjuvant chemotherapy followed by interval debulking surgery. In the first nine patients dosed, GEN-1 plus standard chemotherapy produced impressive results, with no dose limiting toxicities and highly promising efficacy signals in this difficult to treat cancer.

"While the patient number in this trial may be small, the consistency and robust nature of the data across all three cohorts and the encouraging clinical responses underscore the potential of GEN-1 to serve as an effective, safe IL-12 immunotherapy in ovarian cancer," said Nicholas Borys, M.D., Celsion's chief medical officer. "I am particularly impressed with the pathological response data, which is known to be associated with prolonged survival in this patient population. The data generated support continued evaluation of GEN-1 in ovarian cancer, and we look forward to seeing how GEN-1 performs in the fourth and final study cohort."

The OVATION Study is designed to enroll three to six patients per dose cohort with the goal of identifying a safe, tolerable and therapeutically active dose of GEN-1 by recruiting and maximizing an immune response. The first three cohorts each enrolled three patients. Enrollment in the fourth cohort is ongoing, and Celsion expects to complete the OVATION Study this year and report data in early 2017. Future studies of GEN-1 will include a Phase I/II study combining GEN-1 with Avastin® and Doxil®.